Tagrisso

Chemotherapy, Non-Small Cell Lung Cancer, Pharmacotherapy + 2 more

Treatment

7 FDA approvals

20 Active Studies for Tagrisso

What is Tagrisso

Osimertinib

The Generic name of this drug

Treatment Summary

Osimertinib is an oral medication used to treat metastatic non-small cell lung cancer (NSCLC) that has spread despite treatment with other EGFR-TKIs. Around 10% of NSCLC patients have a mutation in their EGFR gene that makes them respond well to this type of drug. This third-generation EGFR-TKI is more specific than previous generations and less toxic, as it only targets the T790M mutation and spares wild-type EGFR.

Tagrisso

is the brand name

image of different drug pills on a surface

Tagrisso Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tagrisso

Osimertinib

2015

2

Approved as Treatment by the FDA

Osimertinib, also known as Tagrisso, is approved by the FDA for 7 uses which include Metastatic Non-Small Cell Lung Cancer and Non-Small Cell Lung Carcinoma (NSCLC) .

Metastatic Non-Small Cell Lung Cancer

Non-Small Cell Lung Carcinoma (NSCLC)

Malignant Neoplasms

Failed Tyrosine Kinase Inhibitors

Non-Small Cell Lung Cancer

Chemotherapy

Pharmacotherapy

Effectiveness

How Tagrisso Affects Patients

A study found that taking osimertinib 80 mg can lead to a 14 millisecond (msec) increase in the QTc interval. However, the upper limit of this increase could be up to 16 msec.

How Tagrisso works in the body

Osimertinib is a drug used to treat non-small cell lung cancer in people with certain mutations in the EGFR gene. It is a type of tyrosine kinase inhibitor (TKI) that specifically targets the T790M mutation, which is associated with a poor prognosis. It has 200 times more affinity for this mutation than for the normal, or wild-type, EGFR gene. Osimertinib is also less likely to bind to the wild-type EGFR, reducing the risk of side effects.

When to interrupt dosage

The prescribed dosage of Tagrisso is dependent on the diagnosed condition. The exact amount varies, in accordance with the method of administration specified in the table below.

Condition

Dosage

Administration

Chemotherapy

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Non-Small Cell Lung Cancer

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Pharmacotherapy

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Malignant Neoplasms

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Failed Tyrosine Kinase Inhibitors

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Warnings

There are 20 known major drug interactions with Tagrisso.

Common Tagrisso Drug Interactions

Drug Name

Risk Level

Description

Ozanimod

Major

Osimertinib may decrease the excretion rate of Ozanimod which could result in a higher serum level.

Rimegepant

Major

The serum concentration of Rimegepant can be increased when it is combined with Osimertinib.

(R)-warfarin

Moderate

The serum concentration of (R)-warfarin can be decreased when it is combined with Osimertinib.

3,5-Diiodotyrosine

Moderate

The therapeutic efficacy of 3,5-Diiodotyrosine can be decreased when used in combination with Osimertinib.

3,5-diiodothyropropionic acid

Moderate

The therapeutic efficacy of 3,5-diiodothyropropionic acid can be decreased when used in combination with Osimertinib.

Tagrisso Toxicity & Overdose Risk

In clinical trials, 3.7% of patients reported lung problems, including fatal cases in 0.3% of patients. There is also a risk of abnormal heart rhythm, so an electrocardiogram and electrolytes should be monitored for those with a history of abnormal heart rhythms. Additionally, 3% of patients reported heart muscle damage, so it is important to measure the left ventricular ejection fraction at the beginning and during treatment. Women should also be aware that osimertinib can cause harm to unborn babies and should use effective birth control during and after treatment.

image of a doctor in a lab doing drug, clinical research

Tagrisso Novel Uses: Which Conditions Have a Clinical Trial Featuring Tagrisso?

Nine active clinical trials are presently underway to evaluate the potential of Tagrisso in treating Malignant Neoplasms.

Condition

Clinical Trials

Trial Phases

Non-Small Cell Lung Cancer

359 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1, Phase 4, Early Phase 1

Pharmacotherapy

0 Actively Recruiting

Malignant Neoplasms

3 Actively Recruiting

Phase 1, Phase 2

Chemotherapy

4 Actively Recruiting

Phase 1, Phase 3, Not Applicable

Failed Tyrosine Kinase Inhibitors

0 Actively Recruiting

Tagrisso Reviews: What are patients saying about Tagrisso?

5

Patient Review

1/13/2019

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

My mom has been taking this treatment for 2.5 years and it's really helped her. She started with Tarceva and then switched to Targrisso after 18 months.

5

Patient Review

7/17/2017

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

I had been taking Tarceva for ten years and it stopped working. My CEA score started rising, so I began Tagrisso in January 2017. Unfortunately, my heart started beating too fast.

5

Patient Review

2/14/2017

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

Tarceva worked for me for six months, and then Optivo for two. Now Tegrisso is showing great improvement in my scans and tumor markers.

1.7

Patient Review

12/19/2018

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

My father died after taking this medication for only three weeks.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tagrisso

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can Tagrisso cure lung cancer?

"AstraZeneca's Tagrisso has been approved by the US Food and Drug Administration (FDA) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent."

Answered by AI

What kind of cancer does Tagrisso treat?

"Tagrisso is a cancer medication used to treat non-small cell lung cancer (NSCLC). It is specifically used to treat patients whose cancer cells have certain mutations in the EGFR gene."

Answered by AI

Is Tagrisso a form of chemotherapy?

"TAGRISSO is a targeted cancer therapy in pill form that is taken once a day, with or without food. Targeted cancer therapies are designed specifically to target certain types of cancer and work by blocking the growth and spread of cancer cells."

Answered by AI

Clinical Trials for Tagrisso

Image of UCLA / Jonsson Comprehensive Cancer Center in Los Angeles, United States.

Telisotuzumab Vedotin + Osimertinib for Non-Small Cell Lung Cancer

18+
All Sexes
Los Angeles, CA

This phase II trial tests how well telisotuzumab vedotin and osimertinib works for the treatment of non small cell lung cancer that is growing, spreading, or getting worse (progressive) and for which no treatment is currently available (incurable). Telisotuzumab vedotin is a monoclonal antibody, called telisotuzumab, linked to a toxic agent, called vedotin. Telisotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as c-Met receptors, and delivers vedotin to kill them. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving telisotuzumab vedotin and osimertinib may be effective for treating progressive, incurable non small cell lung cancer.

Phase 2
Waitlist Available

UCLA / Jonsson Comprehensive Cancer Center

Jonathan W Goldman, MD

AbbVie

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Image of Memorial Sloan Kettering Cancer Center David H, Koch Center lor Cancer Care in New York, United States.

ANS014004 + EGFR-TKI for Non-Small Cell Lung Cancer

18+
All Sexes
New York, NY

Protocol Title A Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer The main purpose of this research study is to Find a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together. Learn how effective this drug combination is at treating a type of lung cancer called "EGFR mutation-positive non-small cell lung cancer (NSCLC)" that has spread to other parts of the body (locally advanced or metastatic). This study is trying to answer the following questions: Safety \& Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well? Effectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing? Background Information For patients with advanced lung cancer that has a specific gene change called an "EGFR mutation," targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called "acquired resistance"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option. How will the study be conducted? This study is divided into two parts: Part 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination. Part 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer. Throughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.

Phase 1 & 2
Waitlist Available

Memorial Sloan Kettering Cancer Center David H, Koch Center lor Cancer Care

Beijing Pearl Biotechnology Limited Liability Company

Image of Research Site in San Antonio, United States.

PLX-61639 for Solid Tumors

18+
All Sexes
San Antonio, TX

A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed/refractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies. The study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase. Participants will receive their assigned dose of PLX-61639 administered orally, once daily until progression/relapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.

Phase 1
Recruiting

Research Site (+9 Sites)

Chief Medical Officer

Plexium, Inc.

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Image of University of California, San Diego Moores Cancer Center in La Jolla, United States.

Retifanlimab + Ruxolitinib for Kidney and Lung Cancer

Any Age
All Sexes
La Jolla, CA

The goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma. The main question it aims to answer is: What is the maximum dose of ruxolitinib that can be used safely in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma, and will it work? Participants will: Take drug ruxolitinib twice a day and keep a diary of when they take ruxolitinib at home; visit the clinic for infusions of retifanlimab every 4 weeks; visit the clinic for checkups and tests.

Phase 1 & 2
Recruiting

University of California, San Diego Moores Cancer Center

Rana McKay

Incyte Corporation

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